NeuroShield— 510(k) K190246

Substantially Equivalent

Monarch Bioimplants GmbH

FDA 510(k) clearance K190246 for NeuroShield, Substantially Equivalent on 2019-05-31. Applicant: Monarch Bioimplants GmbH.

Clearance details

Applicant: Monarch Bioimplants GmbH
Product code: Code JXI
Advisory panel: Neurology
Date received: 2019-02-06
Decision date: 2019-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Root, CH

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